1. Field of the Invention
This invention relates to a method and apparatus for making capsules containing an active medical composition which, if contaminated, would cause substantial injury or even death to a consumer. More particularly, it relates to capsules which provide a visual indication to the consumer when someone has tampered with the capsule.
2. Background of the Invention
Recently, there has been a public outcry to safeguard nonprescription medical products and similar substances. There have been instances where deranged individuals have intentionally contaminated medical products with poisons or other materials that could cause substantial injury or even death to the persons using the products. For example, capsules containing the analgesic Tylenol were poisoned with cyanide and resulted in the death of several people who consumed this poisoned product.
One way to ensure that the consumer will be warned when a capsule has been contaminated is to seal the capsule in such a way that breaking the seal would result in readily apparent structural damage to the capsule, thereby indicating that someone had tampered with the capsule. The problem, however, is to provide a simple and economical way to rapidly seal each individual capsule.
As is well known, capsules currently employed are made of two hard shell, cylindrical members, each having an open end and a closed, rounded end. These members are made of a thermoplastic material such as the gelatin, collagen. This material will dissolve when it is swallowed by the consumer, allowing the contents of the capsule to be ingested. The diameter of these members are such that one is slightly larger than the other, thereby permitting the smaller diameter member, the male member, to be inserted into the larger diameter member, the female member. In accordance with conventional practice, first the male member is filled with the correct dosage of the active composition to be consumed, and then the female member is placed on the male member and the male member is inserted into the female member to form the capsule. Although there have been several methods suggested for sealing the members together, no one has yet discovered an energy-efficient, quick, and economical way in which to do this in such a way that the overlapping wall portions are bonded together so that rupturing the bond breaks the capsule walls.